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Health informatics. Classification of safety risks from health informatics products Ingestion-build-242630 The implementation of ISO 90011 Scope This document is concerned with the safety of patients and gives guidance on the analysis and categorisation of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient. This document applies